# ABC-02: cisplatin plus gemcitabine versus gemcitabine alone for biliary tract cancer

Source: https://onco.cc/key-papers/paper-abc-02-gemcitabine-cisplatin-nejm-2010/  
OnCo record `paper-abc-02-gemcitabine-cisplatin-nejm-2010` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding cisplatin to gemcitabine lengthened survival by more than three months in advanced bile duct and gallbladder cancer without extra serious toxicity, establishing the chemotherapy standard for the disease.

## Summary

Phase 3 trial of 410 patients with locally advanced or metastatic cholangiocarcinoma, gallbladder or ampullary cancer randomised to cisplatin plus gemcitabine or gemcitabine alone for up to 24 weeks.

Median overall survival was 11.7 versus 8.1 months (hazard ratio 0.64) and progression-free survival 8.0 versus 5.0 months, with similar rates of grade 3 to 4 adverse events.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2010
- DOI: 10.1056/NEJMoa0908721
- Authors: Valle J, Wasan H, Palmer DH, et al.
- Findings: Median overall survival 11.7 vs 8.1 months; hazard ratio 0.64.; Median progression-free survival 8.0 vs 5.0 months.
- What it means: Gemcitabine-cisplatin is the backbone of first-line treatment for advanced biliary tract cancer, now combined with durvalumab or pembrolizumab.
- Caveats: Treatment was capped at eight cycles.; Heterogeneous population across biliary sites.

## Sources

- N Engl J Med 2010: https://doi.org/10.1056/NEJMoa0908721
- PubMed: https://pubmed.ncbi.nlm.nih.gov/20375404/

## Connected records

- cancers: [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- trials: [ABC-02](https://onco.cc/trials/abc-02/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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